Real-world Study of Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP) (ORBIT-CIDP)
Study of CIDP Patients with Residual Impairment After Standard Treatment
Study Overview
This study is an observational, ambispective, descriptive, non-interventional study of people with a chronic inflammatory demyelinating polyneuropathy/polyradiculoneuropathy (CIDP) diagnosis in the United States with residual impairment, disability, or neurological deficits after at least three months of treatment with standard of care therapy. The study is expected to last two years. Enrollment is expected to continue for one year. Depending on when the participant is enrolled, a participant can be followed for between one and two years, through the end of study, approximately two years after the study starts.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Polyneuropathy, Inflammatory Demyelinating, Chronic
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
- Neurologist-confirmed diagnosis of CIDP found in the medical record, with the last neurologist visit prior to enrollment containing no information that suggests this diagnosis was reversed
- Active use of at least one of the following CIDP treatments for three months or
longer, with no evidence of discontinuation of this therapy as of the last
neurologist visit prior to enrollment
- immunoglobulin
- corticosteroids, with the exception of prednisone (or equivalent) monotherapy at 10mg or less per day
- plasma exchange
- efgartigimod alfa
- azathioprine
- mycophenolate mofetil
- cyclosporine
- rituximab
- methotrexate
- Signed informed consent
- Residual impairment, disability, or neurological deficits at enrollment, as defined by a raw I-RODS score of 44 or below
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
- Evidence of participation in any interventional clinical trial with an investigational drug at the time of enrollment
- Hyperreflexia (increased reflexes) recorded in the medical record during a neurological exam the year before enrollment and after CIDP diagnosis
- Aged under 18 at the time of enrollment
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
This study investigates chronic inflammatory demyelinating polyneuropathy (CIDP), a condition where the body's immune system attacks the protective covering of the nerves, leading to muscle weakness and numbness. The purpose of this study is to observe individuals in the United States who have been diagnosed with CIDP and continue to have symptoms despite receiving standard care for at least three months.
Participants will undergo observational procedures without any interventional treatments. They will continue their current CIDP treatment, such as immunoglobulin, corticosteroids, or plasma exchange, while researchers collect data on their condition. The study will not involve any experimental drugs or therapies.
- Who can participate: Adults 18 years and older with a neurologist-confirmed diagnosis of CIDP and ongoing symptoms despite treatment may participate. Eligibility includes using CIDP treatments like immunoglobulin or corticosteroids for at least three months.
- Study details: Participants will continue their current CIDP treatment while researchers collect data on their condition. The study does not involve any investigational drugs or therapies.
- Study timelines: The study will last two years.
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